European Commission approves IMCIVREE for treating acquired hypothalamic obesity in adults and children.

Rhythm Pharmaceuticals announced that the European Commission has granted marketing authorization for IMCIVREE (setmelanotide) to treat acquired hypothalamic obesity (HO) in adults and children aged 4 and above. This is the first approved therapy for this rare condition caused by hypothalamic injury, leading to severe obesity and hunger. The approval follows positive Phase 3 trial results showing significant BMI reduction. Rhythm plans to launch the treatment commercially across Europe in 2027 and has already received FDA approval for the U.S. market.